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. 2022 Mar 29;2022(3):CD012867. doi: 10.1002/14651858.CD012867.pub3

NCT04236687.

Study name PAE compared to Holmium laser enucleation of the prostate for BPH
Methods Study design: parallel randomized controlled trial (open label)
Setting/country: single center/Spain
Participants Inclusion criteria: patients evaluated in the urology department and candidates to surgical treatment; age > 45 years; IPSS ≥ 10; Qmax < 12 mL/second; PVR < 300 mL; prostatic volume 20–250 mL assessed by ultrasound; signed informed consent
Interventions Group A: PAE
Group B: Holmium laser enucleation of the prostate
Outcomes Primary outcome
  • Improvement of symptoms assessed by IPSS


Secondary outcomes
  • Qmax

  • PVR

  • PSA

  • Procedure‐related adverse events assessed by Clavien‐Dindo modified score

  • Procedure‐related effects on sexual function assessed by IIEF

  • Procedure‐related effects on urinary continence assessed by the International Consultation on Continence Questionnaire Short Form

Starting date February 2020
Contact information thihag@ous‐hf.no
Notes Sponsor: Hospital Universitari Germans Trias i Pujol